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Nephropathy In Type 2 Diabetes and Cardio-renal Events (NID-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sasso Ferdinando Carlo, Second University of Naples
ClinicalTrials.gov Identifier:
NCT00535925
First received: September 24, 2007
Last updated: December 20, 2011
Last verified: December 2011
History of Changes

September 24, 2007
December 20, 2011
March 2003
July 2012   (final data collection date for primary outcome measure)
CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA)
Complete list of historical versions of study NCT00535925 on ClinicalTrials.gov Archive Site
A) (In patients with microalbuminuria) • Progression to macroalbuminuria • Regression to normoalbuminuria B) (In patients with macroalbuminuria) • Doubling time of serum creatinine • Reduction of proteinuria to <0,5 g/die [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
A) (In patients with microalbuminuria) • Progression to macroalbuminuria • Regression to normoalbuminuria B) (In patients with macroalbuminuria) • Doubling time of serum creatinine • Reduction of proteinuria to <0,5 g/die
Not Provided
Not Provided
 
Nephropathy In Type 2 Diabetes and Cardio-renal Events
Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.

The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:

Phase 1(observational study, completed at 2007): after the identification of a type-2 diabetic population with typical DN, to study of the rate of renal and cardiovascular events during a middle term follow-up.

Phase 2(interventional study, started at 2007): after randomization in two groups, a group (intervention group) is treated with an intensive multifactorial intervention whose aim is to reduce morbidity and mortality due to diabetic complications. The other group (control group) continues the conventional therapy . To avoid bias in the treatment in each center, the randomization was performed for centre.

The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetic Nephropathy
  • Drug: current therapy
    the patients have to be treated according the standard good medical practice by any center
  • Drug: irbesartan

    Therapy for hypertension:

    - Step 1: irbesartan 300 mg/die and ramipril 10 mg/die

  • Drug: ramipril

    Therapy for hypertension:

    - Step 1: irbesartan 300 mg/die and ramipril 10 mg/die

  • Drug: hydrochlorothiazide

    Therapy for hypertension

    - Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)

  • Drug: furosemide

    Therapy for hypertension

    - Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)

  • Drug: amlodipine

    Therapy for hypertension

    - Step 3: amlodipine up to 10 mg/die

  • Drug: atenolol

    Therapy for hypertension

    - Step 4: atenolol up to 100 mg/die

  • Drug: doxazosin

    Therapy for hypertension

    - Step 5: doxazosin up to 4 mg/die

  • Drug: clonidine

    Therapy for hypertension

    - Step 6: clonidine

  • Drug: insulin

    Therapy for Hyperglycaemia (to achieve HbA1c <7):

    - insulin

  • Drug: simvastatin

    Therapy for hypercholesterolemia:

    - for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die

  • Drug: fibrate

    Therapy for hypertriglyceridemia

    - for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate

  • Drug: erythropoietin

    Treatment of anaemia:

    - erythropoietin

  • Drug: aspirin

    Antiplatelet therapy (in all patients without contraindications):

    - aspirin up to 160 mg/die
  • Active Comparator: 1
    Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.
    Intervention: Drug: current therapy
  • Experimental: 2

    An intensive multifactorial intervention is performed to achieve the goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia.

    In particular, new antihypertensive drugs will be added one by one until the achievement of blood pressure target (<130/80 mmHg).

    Interventions:
    • Drug: irbesartan
    • Drug: ramipril
    • Drug: hydrochlorothiazide
    • Drug: furosemide
    • Drug: amlodipine
    • Drug: atenolol
    • Drug: doxazosin
    • Drug: clonidine
    • Drug: insulin
    • Drug: simvastatin
    • Drug: fibrate
    • Drug: erythropoietin
    • Drug: aspirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
850
September 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetic patients
  • AER >30 mg/die (micro- or macro-albuminuric ranges) in at least two determinations in the last six months
  • diabetic retinopathy
  • patients followed in the outpatient clinic for at least 12 months

Exclusion Criteria:

  • type 1 diabetic patients
  • <40 years old
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00535925
246813579
Yes
Sasso Ferdinando Carlo, Second University of Naples
Second University of Naples
Not Provided
Principal Investigator: Ferdinando C Sasso, MD, PhD Second University of Naples
Study Director: Roberto Torella, Prof, MD Second University of Naples
Study Chair: Luca De Nicola, Prof, MD Second University of Naples
Second University of Naples
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP